(22 days)
The TOPAZ Mobile DR System, is a mobile X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy.
This device is not intended for mammography, bone density, fluoroscopy and angiography applications.
The TOPAZ Mobile DR System, (TOPAZ), is a mobile x-ray system and is a modification of the predicate device. There are 2 models for TOPAZ: TOPAZ-32D (32KW) and TOPAZ-40D (40KW). TOPAZ, may be moved quietly and smoothly with a motor drive mechanism.
The core part of x-ray source is a tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD based x-ray control console provides a user-friendly interface and technique selection. The Collimator supports high accuracy for selected x-ray field size over any SID. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique.
The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the workstation and saved in a DICOM file for review on the device or on a Picture Archiving & Communication System (PACS) workstation.
The provided text is a 510(k) summary for the DRGEM TOPAZ Mobile DR System. It discusses the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study that proves the device meets specific acceptance criteria related to a human-in-the-loop or standalone AI performance study.
The "PERFORMANCE DATA" section explicitly states that "Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." This refers to engineering and safety testing against recognized standards (e.g., IEC 60601-2-54, ANSI AAMI ES60601-1, IEC 62304 for software), not clinical performance studies involving AI or human readers.
The key information missing to answer your request is data from a clinical performance study (e.g., diagnostic accuracy, reader study results). The device described is a mobile X-ray imaging system, which captures images. There is no mention of any integrated AI component that would require an AI-specific performance study with acceptance criteria for diagnostic performance.
Therefore, I cannot populate the table or answer most of your questions as the necessary information is not present in the provided document.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
Cannot populate. The document focuses on regulatory compliance and engineering standards for the X-ray system itself, not diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI component. The "acceptance criteria" mentioned are for non-clinical engineering and safety tests, not clinical performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not mentioned for clinical performance. The "test set" referenced in the document pertains to engineering validation and verification tests of the X-ray system's functions, not a clinical data set for evaluating diagnostic performance of an AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not mentioned. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic performance studies. This document reports on non-clinical engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. Adjudication methods are used in reader studies or for ground truth establishment in clinical performance. This document does not describe such studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The document does not describe any standalone algorithm performance testing related to diagnostic accuracy.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable/Not mentioned for clinical performance. For engineering tests, the "ground truth" would be the successful operation of the device according to its specifications and regulatory standards.
8. The sample size for the training set
Not applicable/Not mentioned. This information would be relevant for an AI device. The document describes an X-ray imaging system, not an AI.
9. How the ground truth for the training set was established
Not applicable/Not mentioned. This information would be relevant for an AI device. The document describes an X-ray imaging system, not an AI.
Summary of the Device and its Testing as per the document:
The TOPAZ Mobile DR System is a mobile X-ray imaging system. The 510(k) submission primarily focuses on demonstrating its substantial equivalence to an existing predicate device (K183292, also a TOPAZ Mobile DR System from DRGEM). The main difference for this new 510(k) (K201124) is the addition of five previously cleared digital X-ray detectors to the TOPAZ system.
The "Performance Data" section details that the system underwent non-clinical testing against various recognized international and national standards (e.g., IEC 60601 series for medical electrical equipment safety, radiation protection, usability; IEC 62304 for medical device software; DICOM standards, JPEG standards, etc.). The acceptance criteria for these tests were met, demonstrating the device's safety and effectiveness as an X-ray imaging system, and its performance as well as the predicate device. This refers to the engineering and regulatory compliance of the hardware and integrated software for image acquisition and handling, not the diagnostic interpretation or AI assistance.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.